NCT00323102已完成4 期
Phase IV, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.10 Mmol/kg of MultiHance With 0.10 Omniscan in Magnetic Resonance Imaging (MRI) of the Brain
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Superiority of Multihance in terms of by-patient global diagnostic performance
研究概览
简要总结
This study aims at a direct comparison between Multihance and a validated comparator like Omniscan in a cross-over individual design in patients with brain tumors to confirm the superior overall diagnostic performance of MuliHance for this indication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 yrs of age or older; provide written informed consent; scheduled to undergo MRI; willing to undergo 2 MRI exams within 14 days
排除标准
- •Known allergy to one or more ingredients in the test agents; severe CHF (Class IV); suffered stroke one year ago; pregnancy or lactating females; contraindications to MRI; severe claustrophobia; scheduled to receive surgery prior to or between the two MRI exams, or steroids or radiosurgery between the two MRI exams
结局指标
主要结局
Superiority of Multihance in terms of by-patient global diagnostic performance
时间窗: immediately post dose
次要结局
- To compare the two products in terms of by patients global performance for border delineation of lesions; contrast of lesions(immediately post dose)
- To compare the two products in terms of global changes in lesion count; To compare the two products in terms of changes from pre to post dose in signal intensity(immediately post dose)
研究者
研究点 (2)
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